BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

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    IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517569806·CoRoent Ant TLIF Ti, 12x11x34mm 8°

    Tyber Medical

    FDA UDI
    Tyber Medical, LLC·M695502P221348S1·PLIF 22mm x 8mm x 13mm x 4 °, TyPEEK, Sterile

    Tyber Medical

    FDA UDI
    Tyber Medical, LLC·M695302P221348S1·PLIF 22mm x 8mm x 13mm x 4 °, PEEK, Sterile

    DePuy 3D Additive TriFlange Acetabular Cup

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALPHALOK™ Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·August 12, 2025

    CAPTURE-R READY SCREEN (POOLED CELLS)

    FDA Adverse Event
    Malfunction ·IMMUCOR·Product code KSZ·April 29, 2009

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2014

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JJE·August 24, 2011

    4000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 1, 2013

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 29, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 10, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 22, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·December 27, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·September 16, 2025

    Product Name: Allura Xper FD10C; Model number: 722001;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024